Dura repair with DuraMatrix‑Onlay Plus collagen patch
Official title: Monitoring the Use of Collagen Dural Regeneration Matrix (DuraMatrix-Onlay Plus) in the Postmarket Phase.
Run by Collagen Matrix · NCT06802133 · Data updated 2026-11-12
This will try DuraMatrix‑Onlay Plus, a collagen patch, to seal and repair the dura in patients who need a dura substitute during neurosurgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 118 (estimated) |
| Sponsor | Collagen Matrix Industry-sponsored |
| Locations | 2 sites (Augusta, Georgia and 1 other locations) |
| Status | Recruiting |
| Started | January 13, 2025 |
| Main results expected | May 30, 2026 |
| Study ends | July 30, 2026 |
| Registry record updated | October 15, 2025 |
| Trial ID | NCT06802133 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients who require a dura substitute for repair of the dura mater during neurosurgical procedures and who meet the device's instructions for use are eligible.
✕Probably not a fit
Patients with conditions listed as contraindications in the device's instructions for use or those who do not require a dura substitute are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, post‑market, open‑label observational project at up to eight sites enrolling about 118 subjects who require a dura substitute. Participants will receive DuraMatrix‑Onlay Plus at the time of surgery and be followed for adverse events and the need for revision surgery, with at least one follow‑up around eight weeks to match the device resorption period where possible. The primary endpoint is the rate of revision surgery, and safety outcomes such as CSF leak, infection, and pseudomeningocele will be recorded at each visit. No original patient records or personally identifying information will be disclosed to the sponsor.
Why it matters
Potential benefit: If successful, the device could reduce the need for revision surgery and lower rates of CSF leak after dura repair.
How similar studies have gone: Collagen‑based dural substitutes have been used in clinical practice and prior reports have shown reduced CSF leak rates in some settings, though results vary by product and indication.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The general population will be included in the study where a dura substitute is required for the repair of dura mater. Exclusion Criteria: * Patients that have conditions which are contraindicated per the instructions for use (IFU) would be excluded.
Where it's running
-
Augusta University
Augusta, Georgia, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Meenakshi Paliwal
- Email: mpaliwal@regenity.com
- Phone: 2014051477
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.